OncRef

Clinical Trial: NCT05728268

Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index

Status:

RECRUITING

Phase:

Phase 2

Lead Sponsor:Shantou Central Hospital
Information Provided By:Shantou Central Hospital
Last Update Posted:2026-01-02

Study Overview

Brief Summary

Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.

Official Title

Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: dose-dense nab-paclitaxel followed by EC

Other Study ID Numbers

  • ShantouCH02

Start Date (Actual)

2021-08-01

Primary Completion Date (Actual)

2024-12-30

Study Completion Date (Estimated)

2025-12-30

Enrollment (Estimated)

64

Study Type

Interventional

Phase

Phase 2